Device for removing heat, energy, and/or fluid from a living mammal

ABSTRACT

The present invention provides improved devices for removing energy and fluid from body fluid containing spaces and surfaces of a mammal, the devices including isolated air and water delivery systems configured to simultaneously deliver streams of dry air and liquid water to the nostrils of a patient, without allowing the streams to come into contact with one-another until it enters the patient&#39;s nostrils.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The invention relates generally to methods and devices for removingheat, energy, and/or fluid from a living mammal

2. Background Information

Methods and devices for non-invasive anatomical and systemic cooling andneuroprotection are disclosed in U.S. patent application Ser. Nos.13/579,370 and 14/578,094.

SUMMARY OF THE INVENTION

The present inventions include improvements to the devices disclosed inU.S. patent application Ser. No. 13/579,370 and U.S. patent applicationSer. No. 14/578,094, the disclosures of which are incorporated herein intheir entirety.

Evaporative cooling is a physical phenomenon in which the evaporation ofa liquid results in the cooling of an object or a liquid in contact withit, due to the fact that it requires heat or energy to change a liquidinto a gas. The amount of energy required to change a liquid to a gas isdirectly proportional to the total mass of liquid that is changed to agas and the enthalpy of vaporization. Enthalpy of vaporization, alsoreferred to as latent heat of vaporization, is the amount of energyrequired to transform a given quantity of a substance from a liquid intoa gas. Different liquids have different enthalpies of vaporization.

The present invention makes use of this phenomenon to achieve energy andfluid removal from the human body. According to the invention, dry airis blown across a patient's nasal turbinates which promotes theevaporation of liquid water in and on the nasal turbinates. The heat orenergy needed to vaporize the water is extracted from the host surfaceand transported out of the body. According to a preferred embodiment, asupply of misted water, preferably saline solution, is provided to thenose without being exposed to the dry air stream prior to the point ofdelivery at the entrance to the patient's nose. The supplied salinesolution is used to both support or augment the evaporative heattransfer process (supplementing the body's naturally occurring watergenerating mucus membranes), and to help reduce or eliminate thepotential to desiccate the local tissue in the air pathway if thepatient's native water is evaporated from the patient's body during theprocess.

The dry air stream and the water is provided to the patient via isolateddelivery paths using a specially designed device, tubes, and mask whichdeliver the dry air and the water to the patient at a delivery point ator just inside the nostril openings, up to which point the separate dryair and water flow paths have been kept isolated from one-another. Noportion of the device is required to be inserted into the nasal cavity.

According to various aspects of the invention, therefore, there isprovided a method and an improved device for removing heat and/or otherenergy from a mammal; cooling an anatomical feature in a mammal (e.g.,preferential brain cooling), providing systemic cooling in a mammal,removing excess fluid from a mammal, raising the metabolic rate of amammal, promoting weight loss in a mammal, prevention of esophagealburn-through during catheter ablation treatment for atrial fibrillation,reduction or inhibition of β-amyloid accumulation in a mammal,amelioration of pain due to migraine, amelioration of insomnia, and/ordelay in onset or amelioration of senile dementia and/or Alzheimer's ina human, by controlled, induced evaporation of a bodily fluid from abodily fluid-containing space or surface, such as the nasal turbinatesof a mammal The method includes simultaneously delivering isolated flowsof a dry gas (compressed or not) which does not include a coolant (i.e.,a refrigerant or chilled gas or vapor) with or without water into orupon the bodily fluid-containing space or surface to provide controlledevaporation and transport (removal) of the bodily fluid upon contactwith the dry gas. Such evaporation and transport of the bodily fluidremoves heat, energy and fluid from the body.

The device is configured to be lightweight and portable, and may beconfigured to operate via connection to standard wall socket and/oroptionally by onboard rechargeable battery.

The device draws air from either the ambient room through a filteredinlet plenum or from a hospital wall pressurized air source through aninlet valve and dries the air for delivery to the patient. Once insidethe device, the air path passes through an inlet plenum pathway, a bulkplenum pathway, a desiccant cartridge, a heat sink, across varioussensors and out an air outlet. While inside the device the airflow pathis isolated from entrance to exit. The device also has a separate waterdelivery system which keeps the water flow path isolated from the airflow path. The water delivery system includes a water supply tube fittedwith a saline bag spike at one end, continuously passing through awater/air manifold cartridge, and ending at misting nozzles at the otherend. The water/air manifold cartridge has a dual function of interfacingthe water supply tube with a peristaltic pump in the device, andcombining the isolated water and air delivery paths into an integratedtube set but which maintains separately the isolation of the water andair supply lines.

According to a preferred embodiment, the device according to theinvention has a portable housing having an air inlet and air outletconnected by an air flow path through the device, a fan situated in thehousing to draw air from an air supply through the air inlet, throughthe air flow path and out the air outlet into an air delivery tube, asingle use replaceable desiccant cartridge situated in the air flow pathto dry the air, a heat sink to remove heat generated as a byproduct ofextracting moisture from the air stream, a peristaltic rotary fluid pumpsituated in the housing to draw fluid from an independent fluid supplythrough a fluid supply line and deliver it to the patient through anisolated fluid delivery line. The device also includes temperature,humidity, pressure, and flow sensors as well as inputs for patienttemperature sensors, and one or more batteries along with standardconnections for wall power (110V-240V). In addition, the deviceinterface may be configured to allow an operator to manually select thedosing level, which will set the air flow rate (from low to high, inmultiple increments). The device may also be used in a closed-loopcontrol mode, with a proportional-integral-derivative (PID) controlsystem (processor/controller and software), that allows the operator toset a target body temperature for the patient. According to thisembodiment, the device has an input port for receiving a patenttemperature monitor output plug that allows the patient's temperature tobe continuously fed into the device. The PID control system can be setto automatically control the air flow to the patient, generally withhigh air flow during the initial temperature ramp down period, and thenreduced air flow to maintain the target temperature once reached. ThePID controller monitors and sets air flow supplied to the patient usingthree separate inputs: pressure of the air supplied to the patient,temperature of the air supplied to the patient, and the air flow rateitself. The PID control system monitors each of these parametersseparately to ensure patient safety, e.g., that the supplied airpressure, air temperature, and air flow rate to the patient do not gettoo high.

According to further preferred embodiments, there is provided accordingto the invention a replaceable manifold assembly/cartridge configured tobe placed into complimentarily shaped interface in a side of the housingin order to engage with the peristaltic water pump and to separatelyengage with the airflow outlet. The manifold cartridge is attachedto/part of an integrated tubeset including an air delivery tube fordelivering the dry air to the patient and a water delivery tube fordelivering an isolated stream of water to the patient.

At some point before it reaches the patient, the tubeset bifurcates intotwo sets of air/water delivery tubes, one for each of a patient'snostrils.

At the opposite end of the tubeset, the two sets of air delivery tubesand isolated water delivery tubes contained therein are connected to aspecially designed patient interface/delivery apparatus configured tosimultaneously delivery separate streams of dry air and water to thepatient's nose at the nostril openings.

According to a preferred embodiment of the invention, the patientinterface device includes a flexible plastic strip configured to rest onor just above a patient's lip, just beneath the nose, and extending oneither side of the nose, resting against the patient's face to a pointbetween the patient's cheek bones and ears. Opposite ends of the stripare connected to an adjustable strap to hold the device to the user'sface. The center portion of the bridge defines one or more slots toslidably/adjustably receive the ends of the tubeset to accommodate arange of different distances between the center of the patient'snostrils. The ends of the air tubes are fitted with nasal pillowsconfigured to rest at the entrance of a patient's nostrils. The ends ofthe water delivery tubes are fitted with nozzles, which are locatedprimarily inside the nasal pillows and partially extending outward (afew millimeters) from the center of the nasal pillow air outlets so thatthe water stream and the air stream are completely isolated fromone-another until the point of delivery in the nose.

No portion of the device covers the user's chin, jawline, or mouth, orany part of the user's nose except the nostrils.

The invention is particularly well suited to use in ambulatorytherapies, including emergency settings, combat settings, sportsettings, and even clinic and home-use settings.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features and advantages of the disclosure will become moreapparent by the following detailed description of several embodimentsthereof with reference to the attached drawings, of which:

FIG. 1 is a schematic of a device according to an embodiment of theinvention.

FIG. 2 is a three dimensional perspective representation of a deviceaccording to a preferred embodiment of the invention.

FIG. 3 is a see-through three-dimensional perspective view of a top partassembly of a device according to an embodiment of the invention.

FIG. 4 is a three-dimensional color representation of a bottom partassembly of a device according to an embodiment of the invention.

FIG. 5 is a perspective view schematic of a bottom part assembly of adevice according to an embodiment of the invention.

FIG. 6 is a three dimensional color cutaway perspective representationof a bottom part assembly of a device according to an embodiment of theinvention.

FIG. 7 is a side cutaway view of a bottom part assembly of a deviceaccording to an embodiment of the invention.

FIG. 8 shows cutaway views of the desiccant cartridge.

FIG. 9 is a cutaway view of a back end of a device according to anembodiment of the invention.

FIG. 10 is a see-through perspective representation of a back-side of adevice according to the invention showing a port that is used tointerface with hospital-supply gas.

FIG. 11 is a close-up view of a right side portion of the view shown inFIG. 9, with arrows showing the air flow when the device is hooked up toa hospital/pressurized gas source through the gas port.

FIG. 12 is a three-dimensional front perspective view of a fluid pumpassembly according to an embodiment of the invention

FIG. 13 is a three-dimensional top and side perspective view of a fluidpump assembly according to an embodiment of the invention.

FIG. 14 is a three-dimensional close-up front perspective view of afluid pump assembly according to an embodiment of the invention.

FIG. 15 is a perspective view of a manifold cartridge according to anembodiment of the invention.

FIG. 16a is an exploded perspective view of the manifold cartridge shownin FIG. 15.

FIG. 16b is a cutaway view of the manifold cartridge showing theconnection between the water delivery line, the transfer tube and thewater supply line.

FIG. 17 is an assembly view of the disposable patient set, specifically,a manifold cartridge assembly attached to a tubeset (an air deliverytube containing within its lumen an isolated a water delivery tube)which in turn is connected to a patient interface device.

FIG. 18 is a top perspective view of a combined air and water deliverypatient interface device according to an embodiment of the invention.

FIG. 19 is a front view of a combined air and water delivery patientinterface device according to an embodiment of the invention.

FIG. 20 is an exploded view of a combined air and water deliveryassembly patient interface device according to an embodiment of theinvention.

FIG. 21 is a three-dimensional close-up front perspective view of afluid pump assembly according to an embodiment of the invention in whichthe forward most elements of the pump assembly housing are shown inphantom.

DETAILED DESCRIPTION OF THE INVENTION

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the invention, the preferred methods andmaterials are now described.

As used herein, “relative humidity” is used to refer to the amount ofwater vapor that exists in a gaseous mixture of gas and water vapor as afunction of its current state, for example temperature. Essentially,relative humidity is a measure of the amount of moisture in the aircompared to what the air is capable of holding at a given temperatureand pressure. In various embodiments, the relative humidity of the gasbefore being contacted with a bodily fluid or delivered misted liquid isless than or equal to about 50, 40, 30, 20, 10, 5 or 0%. In variousembodiments, the relative humidity of the gas after being contacted witha bodily fluid is greater than or equal to about 60, 70, 80, 90 or 100%.

As used herein, a “dry” gas is used to refer to a gas that isunsaturated with water vapor or other liquid vapor. In variousembodiments, the dry gas has a relative humidity of less than or equalto about 50, 40, 30, 20, 10, 5 or 0%.

Several types of gases are suitable for use with the present invention,specifically those that can induce or enhance an evaporative heatexchange process with the body's existing mucus (water) liquid and/orwith other liquids supplied by the invention. Such gases include, butare not limited to air, NO₂, CO₂, O₂, and inert gases, such as He, Ar,and Xe, as well as combinations thereof.

The dry gas delivered according to the invention does not include acoolant. As used herein, the term “coolant” includes volatile gases andmay include dry ice, liquid nitrogen, chilled saline, chilled water,anti-freeze solution, refrigerants, such as fluorocarbons,chlorofluorocarbons (CFCs), hydrochlorofluorocarbons (HCFCs),perfluorocarbons (PFCs), R-134a (1,1,1,2 tetrafluoro ethane), Freon™,and other cooling fluids or refrigerants, or a combination thereof. Acoolant may also be considered any fluid chilled to a temperature 10° C.or more below normal body temperature. For humans, a coolant would thusbe a fluid chilled to about 27, 26, 25, 24, 23, 22, 21, 20, 19, 18, 17,16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0° C. or less.

In preferred embodiments of the invention, the dry gas used with thedevice is air or oxygen, supplied at temperatures from 0° C. up to about40° C., preferably above 20° C., more preferably at or above 23° C., butin any event no greater than 40° C.

According to a preferred embodiment of the invention, the administrationof the dry gas accompanied by the simultaneous delivery of an isolatedsupply of a liquid to supplements the evaporative heat exchange processinside the body, as well as possibly protecting the body fromdesiccation. In cases where the liquid is water-based, the added water(supplied by the device) can also be used to help reduce or eliminatethe amount of the patient's native water that otherwise would beevaporated from the patient's body during the process, thereby reducingor eliminating a ‘desiccating’ effect from the evaporative process.Although, in some clinical cases, the goal is to desiccate the patient,i.e., remove water, in which case no added water would be supplied tothe patient from the device.

In preferred embodiments of the invention, the liquid will be a salinesolution that approximately matches the saline content of the humanbody, supplied at temperatures from ambient temperature, to normal bodytemperature (e.g., for humans, 37° C.), and even as warm as a highestclinically acceptable temperature, with liquid at the ambientenvironmental temperature being particularly suitable for ambulatorysettings, especially in emergency contexts. The invention may use liquidtemperatures from (ambient temperature) C up to about 40° C., as 40° C.is considered a clinically acceptable temperature.

According to various embodiments, the invention monitors amount of drygas supplied to the patient's nostrils and simultaneously supplies, viaan isolated delivery path and misting nozzles located at the opening ofthe patient's nostrils, the amount of corresponding liquid needed tosupport an evaporative heat transfer process. In preferred embodimentsof the invention, the gas is air and the liquid is saline, and theamount of saline needed is calculated by the device to match the watercarrying capacity of the volume of air being delivered by the device.This is done by measuring the volume of air being delivered, i.e., theair flow rate and time, as well as the temperature and humidity of theair being delivered. The device uses this to calculate the water holdingcapacity of the supplied air and then delivers a corresponding amount ofsaline. The amount of liquid supplied can be adjusted by the device tomatch exactly with the water holding capacity of the air being supplied,or it can be adjusted to supply more or less liquid, depending on theclinical need.

The invention may utilize high flow of gas, which includes flow rates ofbetween about 20 and 200 L/min, between about 40 and 130 L/min, betweenabout 20 and 80 L/min, between about 40 and 500 L/min, between about 100and 500 L/min, or between about 200 and 500 L/min. For example, gas maybe delivered at a flow rate of greater than about 10, 15, 20, 25, 30,35, 40, 45, 50, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120,125, and 130 L/min. As discussed herein, the flow rate may be variedthroughout the duration of delivery to maximize evaporation within or onthe bodily fluid-containing space or surface.

FIG. 1 shows a schematic of a device according to one embodiment of theinvention in which air flow is generated by fan/blower 101, and in whichthe air flow passes through or by air flow sensor 103,disposable/replaceable desiccant cartridge 105, heat sink 106, humidity,pressure and temperature sensor(s) 107, saline bag 500, peristaltic pump159, manifold cartridge 137. According to the embodiment shown in FIG.1, after the air has left the device and has moved into the manifoldcartridge 137, it passes through disposable filter 109, tubing 111, andnasal mask 113 for delivery to the patient. Flow sensor, heat sink,and/or humidity, temperature and pressure sensors communicate withprocessor or custom board 115, which in turn drives the display anddevice interface 117. Power source 119 may be A/C or D/C, and may besupplied by on-board battery or external power source.

FIG. 2 shows a representation of a portable device according to anembodiment of the invention. The device will be located next to thepatient when in use and will either be mounted on an IV pole or placedon a horizontal surface. The device is comprised of multiplesubassemblies which can be assembled largely independently. At thehighest level, the device consists of top and bottom subassemblies 10,30, respectively, which contain all other subassemblies. FIG. 3 showsthe top subassembly 10 which includes a user interface 12 which consistsof a LCD screen 14 and a membrane panel 16, a hatch 18 and a compartment20 for receiving the desiccant cartridge 105, and an inlet 26 (See FIG.10) and valve 24 for hospital wall pressurized air supply (whenavailable). The device bottom subassembly 30, shown, inter alia, inFIGS. 4-7, contains the airflow subassembly, the fluid pump assembly,and the main electrical subassembly.

The airflow subassembly includes the following parts; air inlet 32,inlet plenum 149, inlet filter 34, pressurized air inlet 26 and valve24, blower/fan 101, blower plenum 121, desiccant cartridge 105,desiccant filter 123, intermediate plenum 125, heat sink 106 and heatsink fan 127, pressure sensors 129, temperature sensors 131, humiditysensors 133 and air outlet135.

Air is driven through the system by the centrifugal blower 101. The airenters the device either through an inlet 32 and filter 34 in the sideof the device or through an inlet 26 and valve 24 for pressurizedhospital wall air and exits into an open air inlet plenum 149 where theblower 101 creates suction. The air then enters the blower 101 and exitsinto a small chamber/blower plenum 121 in the base plate, which leadsinto the desiccant cartridge 105. The air is dried as it flows throughthe desiccant cartridge 105, which contains a molecular sieve materialthat adsorbs water. A high efficiency bacterial/viral filter 123 isincluded at the outlet of each desiccant cartridge 105 in order toprotect the patient from any contaminates, debris, or dust in thedesiccant cartridge or the incoming air stream. The air then moves intoa larger chamber/intermediate plenum 125 and past the heatsink 106,before passing by an array of sensors and out into the disposablemanifold 137.

In an alternative embodiment of the device, the dry gas will have aseparate path where it is driven through the device and supplied to thepatient only by means of a high pressure of gas supplied from an outsidesource, such as a tank of air or oxygen, or the wall port of a room inthe hospital. In this embodiment, the supplied air enters the devicethrough an inlet 26 and runs through one or more pressure regulatorsand/or valves that are used to regulate the pressure of the dry gas,such as air or oxygen, down to a level that is appropriate and safe todeliver to the patient. The supplied air will still run through thedesiccant cartridge 105, which contains a molecular sieve material thatadsorbs water, as well as a high efficiency bacterial/viral filter 123.The supplied air may also still run through the fan 101 though that fanwill be powered off during use with the pressurized gas source. As partof this embodiment, the device will recognize when the high pressuresupply of gas is turned off or disconnected, at which point the devicewill automatically start and run the centrifugal fan 101, which willthen provide the motive force to supply a flow of dry gas to thepatient.

FIG. 8 shows an embodiment of a disposable cartridge 105 which may becomposed of three primary components: a main body, a cap, and a central“straw”. There may also be a mesh to contain the desiccant material (soit cannot leak out of the cartridge), an assembly to capture a highefficiency bacterial/viral filter 123, and a pair of O-rings to create aseal between the disposable cartridge and the device. To assemble thecartridge, the top cap is removed and the straw with filter assembly isplaced into the body and held in place by a friction fit. Ribs may beprovided to act as standoffs, holding the filter assembly slightly abovethe bottom of the cartridge. In addition to adding strength to the body,these ribs may also offset the mesh above the body surface, allowing forgreater airflow. The desiccant material is then poured into the body,then the top mesh may be placed on top of the molecular sieve at thelocation shown in FIG. 8. Finally, the cap is snapped on or otherwiseattached. The O-rings are preferably configured to mate with a pair offemale features in the device, creating radial seals that separate theinlet from the outlet.

A detection switch 139 is triggered when the desiccant cartridge 105 isfully inserted. When this switch is open, the system will not turn onthe blower 101 because the airflow path is not complete. The switch ispositioned such that it will always trigger when the desiccant is fullyseated, but will not trigger when the cartridge is only partiallyinstalled, as the cartridge's O-ring seals are not reliable at thatpoint and air may be able to bypass the cartridge or escape the device.

The desiccant material has a limited capacity to adsorb moisture. Whenit becomes exhausted, the cartridge must be replaced with one containingfresh desiccant material. The time to exhaustion is dependent on boththe moisture content and flowrate of the incoming air.

The removal of moisture from the air by the desiccant cartridge 105produces heat, with the air temperature at cartridge exit reachingtemperatures in excess of 70° C. in some cases. To cool the air beforeit reaches the patient, a custom two-sided heatsink 106 is positioneddownstream of the desiccant cartridge 105. The hot side 141 of theheatsink 106 is directly in the dry air stream. A fan 127 draws ambientair into the housing via second air inlet 132 and forces it across theother side 143 of the heatsink, cooling the dry air. The fan also has abuilt-in tachometer, allowing the speed to be actively controlled basedon outlet air temperature. A flange 147 on the heatsink 106 separatesthe two airflows but allows the communication of heat across the flange.Due to the difference in temperature between the two airstreams, theheatsink 106 conducts heat away from the air on the primary (hot) side141 and warms the ambient air provided by the cooling fan 127 on thesecondary side 143. Once the cooling air has blown through the heatsink106 and absorbed heat, it exits the device through vents in the devicebottom.

The device is capable of connecting to a pressurized medical airsource/tank with standard medical gas tubing and fittings as commonlyfound in hospitals and other medical settings. The medical air is dryerthan ambient air in most cases. A solenoid valve 24 is openedautomatically when the blower 101 is turned on. Air is supplied to thisvalve through a standard medical air hose. A¼″ NPT fitting 28 on therear of the device is attached to the valve inlet 26 through a reducingfitting, and a medical air hose-compatible fitting (which interfaceswith the medical air hose) is attached to the NPT fitting 28.

A built-in orifice in the valve 24 limits the airflow entering thedevice. Air exiting the valve 24 is directed into the inlet plenum 149at the blower input through a section of tubing and then follows the airflow path described above with respect to ambient air supply. Sincethere is a small positive pressure in the filtered inlet plenum 149 whendrawing from the pressurized wall air source, some air will be exhaustedfrom the device through the inlet manifold grill 151.

Three pressure taps 153, two on base plate—lid and one on baseplate—base, attach to pressure sensors 129 on the PCB via ⅛″ ID PVCtubing. The tap directly preceding the end of the device airflow pathconnects to the outlet pressure sensor 129 a. After passing through theblower 101, for the remainder of the airflow pathway the air isoperating at higher pressure than the ambient environment (this isrequired for airflow). The pressure sensor 129 a acts as a safetymechanism, ensuring the pressure does not rise to a level unsafe for thepatient. The placement of the pressure sensor 129 a is conservative, asit is at the beginning of the tubeset 157. The airflow will drop inpressure over the course of the tubeset (due to tubeset resistance), andthus the measured value in the device will always be higher than thatwhich the patient experiences.

The other two pressure taps 153 connect to a sensor 129 b measuring thepressure differential across the desiccant cartridge to calculateflowrate.

In addition to the tap for the outlet pressure sensor 129 a, a humiditysensor 133 and pair of thermistors 131 are also positioned by theairflow path outlet. Grommets ensure that air is not able to escapearound these sensors. The air may experience a temperature drop as itpasses through the tubing, as the air inside the device is almost alwayseither hotter than or equal to ambient temperature. As the air passesthrough the tubeset, it is surrounded by ambient air, which will almostalways be cooler than or equal to airstream temperature. Some amount ofenergy will be transferred to ambient through the tubing walls, coolingthe air stream. The only case in which air temperature would rise whilepassing through the tubeset is when air stream temperature is lower thanambient temperature, in which case the air stream will never heat up toa temperature higher than ambient temperature.

The air delivered to the patient is filtered at three separatelocations: the inlet filter 34 at the entrance to the device; thedesiccant filter 123 after passing through desiccant material, and thepatient filter (Disposable Manifold Filter) 109 upon exiting the deviceand entering the tubeset. The desiccant filter 123 and the patientfilter 109 are contained within disposable elements, and will bereplaced for each patient when new disposable elements are used.

The fluid pump assembly 159, shown in FIGS. 12-14, provides theinterface between the peristaltic pump 160 and the disposable manifoldcartridge 137 for saline dispensing. The pump 160 is composed of astepper motor 161 and matching pump head 163. Two bearings in the pumphead provide translational support but allow rotation of the pump rotor165 and its four free-spinning rollers 167. The pump is mounted onto ahinged plate 169, and positioned using a rotary knob 171 and linkage173. A ball detent 175 behind the knob 171 helps to maintain the pumpposition when it is fully opened or closed. When closed, the linkage 173is in an over-center position, keeping it securely fastened when upwardforce is applied by the section of tubing 177 it has engaged.

The knob 171 rotates approximately 100°, from roughly the 9 o'clockposition when opened to the 6 o'clock position when closed.

The pump rotor 165 forces the tubing 177 from its horizontal alignmentinto a curved profile dictated by the pump platen 179. The tubing isclamped between the rollers on the pump rotor and the platen, fullyoccluding the tubing and preventing flow in either direction when thepump is stationary. A spring 181 between the linkage 173 and pump mount185 makes the loading of the tubing 177 force-based rather thandisplacement-based, which improves reliability and reduces wear.

The assembly also includes two inputs. First, a lever-arm limit switch187 to detect when the disposable manifold 137 is installed. The limitswitch 187 is triggered by a small cantilevered rib 189 on thedisposable manifold cartridge 137. This rib is purposely biased upwardsto ensure that it reliably makes contact with the limit switch 187. Therib length has been optimized to ensure that the switch is not triggereduntil the manifold is fully installed. Two ball spring plungers 193protruding up from the bottom of the assembly interface with detents inthe disposable manifold 137 and cause the manifold to snap into place,reducing the variability of manifold placement and preventing themanifold from unintentionally slipping out of place when the knob isopen.

In addition to the limit switch, the assembly also contains theocclusion sensor 195 which is a small force transducer mounted on abasic PCB (see FIG. 21). The top side of a thin stainless steel plate197 is pressed against the transducer. When the knob is closed, thebottom side of the plate 197 is pressed against the pump tubing,translating the force to the occlusion sensor. This is used to examinethe pressure in the tubing during dispenses and determine whether eachdispense was successful. This is possible because a successful dispensecreates a distinct pressure profile. The plate's flat profile andcantilever mounting also help to compensate for any variation in thepump tubing alignment.

The occlusion sensor 195 is capable of detecting various error cases,such as leaks, occlusions, and air in the line. In the case of an emptysource container, the device can use the sensor to determine when theline has been successfully re-primed. The occlusion sensor 195 alsoserves as a means to detect when the pump is latched down, as the tubingbecomes compressed at this point and thus applies a force to the sensor(no force is applied to the sensor when unlatched).

The pump platen 179 provides an appropriate surface to support andposition the tubing 177 during pumping, but it also serves two ancillaryfunctions. The limit switch 187 and ball spring plungers 193 are mountedto it, and it also creates a sealed airflow path from the device to themanifold 137. This is accomplished with one gasket and one grommet Thefirst is a rod-wiper type rubber grommet 199 in a steel housing, whichcreates a radial seal with the manifold. The second is a foam face sealgasket 201 that seals the platen to the airflow path in the base plate.

The manifold cartridge 137 preferably has a base part 203 and a lid part205, each of which have a device side and a side that faces away fromthe device (an away side). The away side of the base part 203 faces thedevice side of the lid part 205, and when connected, the base part 203and the lid part 205 define a space 206 between them, which preferablycontains an air filter 109. The away side of the lid part 205 has an airdelivery port 207 for connecting to an air delivery tube 221. The deviceside of the base part 203 has an air receiving section 209 configured tofit snugly into the air outlet 135 of the housing via rubber grommet 199and a water supply section 211 configured to interface with the fluidpump. The water supply section 211 includes a disposable flexibletransfer tube 177 configured to connect to an independent water supply,e.g., a saline bag, at one end via water supply tube 319 and connectedto a water transfer port/opening 215 in the device side of the base part203. When the manifold cartridge 137 is inserted into thecomplimentarily shaped interface 216 in the device housing, the rotaryfluid pump engages the flexible transfer tube 177. When the fluid pumpis activated, the rotating arm of the rotary fluid pump rotates,squeezing the flexible transfer tube 177 against a curved surface (theplaten 179) of the fluid pump causing fluid in the fluid supply to bedrawn into and forced through the transfer tube 177. The water transferport 215 in the device side of the base part 203 is connected to acorresponding water transfer port 217 on the away side of the base part.A water delivery tube 219 is connected to the device side water transferport and travels through the space 206 between the base part and the lidpart (through a small hole in the air filter, if provided) and outthrough the air delivery port 207, into the air delivery tube 221. Thatis, the air delivery tube 221 is sized to fit snugly onto or inside ofthe air delivery port 207. The water delivery tube 219 exits the airdelivery port 207 and travels through the inside of the air deliverytube 221, thereby independently delivering isolated streams of dry airand water to the patient. According to an alternative embodiment, thewater delivery tube 219 may be arranged so that it does not pass throughthe air filter

At some point before it reaches the patient, the air delivery tube 221,containing within its lumen the independent and isolated water deliverytube 229, preferably bifurcates to provide two separate distal airdelivery tubes 223. The bifurcation of the air delivery tube can beaccomplished according to any known means, including a one-to-twoconnection element 225 Similarly, and preferably at about the samelocation, the single water delivery tube 219 is similarly bifurcatedinto two separate distal water delivery tubes 227, each of whichcontinues to travel within a corresponding distal air delivery tube.

The distal air delivery tubes 223 terminate at bridge connectors 229which connect to a slot in bridge 231 in which they can translate fromside to side. The bridge 231 is preferably a flexible plastic stripconfigured to rest on or just above a patient's top lip, just beneaththe nose, and preferably extending on either side of the nose restingagainst the patient's face to a point between the patient's cheek bonesand ears. Opposite ends of the bridge 231 are adapted to receive anadjustable strap assembly 233 that goes around the back of the patient'shead to hold the bridge 231 to the user's face. The center portion ofthe bridge defines one or more slots 235 to receive neck portions of thebridge connectors 229, allowing them to slide back and forth toaccommodate different nose sizes/nostril separation distances.

The ends of the distal water delivery tubes 227 are fitted with nozzleadaptors 237 which in turn are connected to nozzle components 239 eachcomprising a ring-shaped base 241 and a central nozzle 243 connected tothe ring-shaped base 241 by a three or more upwardly extending spokes245 that support and center the nozzle. Nozzle components 239 and nozzleadaptors 237 are preferably press fit together and the interface betweenthem creates a swirl chamber geometry that generates spray. The nozzleassemblies 239 are connected to the distal ends of respective bridgeconnector 229 by flexible elastomeric nasal pillows 247. The bottomopening 255 of the nasal pillows are sized to stretch fit over thedistal end of the bridge connectors 229 just above where they interfacewith the bridge 231. The distal ends of the bridge connectors 229 arepreferably formed with an outwardly extending flange 249 to bettersecure the elastic bottom neck of the nasal pillows. The bottom ringportion 241 of the nozzle component 239 rests in a wide but shortshoulder portion 251 of the nasal pillow 247 that tapers to openings atthe bottom end 255 and top end 253, respectively, and the pillow andnozzle assembly are sized so that the top of the nozzle component 239extends through the center of the opening 253 at the nozzle end of thepillow without contacting the edges of the pillow opening. In thisfashion, the water stream and the air stream are completely isolatedfrom one-another until the point of delivery.

In various embodiments, the device may further include additionalfeatures that allow for the introduced fluid to be exhausted from thebodily fluid-containing cavity; see U.S. patent application Ser. No.13/579,370 paragraph [0047], which is incorporated herein by reference.

The device may include a number of additional features to assist inregulating gas flow and pressure to achieve fluid elimination, anatomicor systemic cooling, energy removal, metabolic rate adjustment and/orweight loss. The device may further include a temperature sensor and/orpressure sensor for dynamic feedback and control of the gas temperature,pressure, and gas flow; see U.S. patent application Ser. No. 13/579,370,paragraph [0057], which is incorporated herein by reference.

The duration of treatment will vary depending on the desired level offluid elimination, anatomic or systemic cooling, energy removal,metabolic rate adjustment and/or weight loss.

Unless otherwise set forth herein, the embodiments described above aregenerally directed towards creating a positive pressure source to blowdry air into the nose and nasal turbinates, which induces theevaporative phenomenon. According to these embodiments, air entersthrough the nose and exits the mouth, and about 20 to 30 cm of water ofpressure is generated in order to create the preferred air flowaccording to most preferred embodiments, but other embodiments usepressures up to 40 cm, 50 cm and 60 cm of water pressure.

However, testing using these embodiments has shown that as pressure isincreased, the fine vasculature in the turbinates may be compressed,possibly causing a reduction in blood flow and water supply, which inturn could reduce the vascular supply of heat which is needed to supportevaporative cooling. As such, evaporation (from any surface) andresulting heat removal could decrease as air pressure increases.

Accordingly, the present invention also includes the creation of airflow over the nasal turbinates through the use of a vacuum or othersuction. According to these embodiments, two air tubes would beprovided, one connected to each nostril. A negative pressure source(e.g., a fan) or vacuum source is connected on one side to pull dry airinto the other side. The dry air enters a first nostril, travels acrossone side of the turbinates, and goes out the other nostril (the sidewith the negative pressure source). This negative pressure/vacuum sourcealso causes vasodilation, which could improve the vascular supply ofheat and thus improve the evaporative model, even beyond normalrespiratory conditions. This embodiment of the invention has anadditional benefit in that the user need not be concerned about ventingfrom the mouth; that is, the mouth need not be kept open. Thisembodiment is also unaffected by possible occlusions in the upperairway, which could block air flow according to other embodiments.According to a preferred embodiment, the fan or vacuum causes air to bedrawn through a desiccant cartridge prior to entering the first nostril.According to another embodiment, a blower may be provided at the inletside so that the net gage pressure across the turbinates is very low orzero, with the positive pressure fan/blower and the negative pressurevacuum source balancing one-another out. According to anotherembodiment, a blower may be provided at the inlet side on one nostriland open to atmosphere on the other. According to embodiments where avacuum source is provided at one nostril, a seal may be placed betweenthe inlet nostril and the inlet tube to prevent or inhibit the entry ofambient (non-desiccated) air from entering the inlet nostril.

Although the invention has been described with reference to the aboveexample, it will be understood that modifications and variations areencompassed within the spirit and scope of the invention. Accordingly,the invention is limited only by the following claims.

1. A device for inducing evaporation of a fluid from a bodilyfluid-containing space in a mammal, the device comprising, in anintegrated unit: air delivery subassembly comprising: an air inlet, anair outlet, an air flow path connecting said air inlet and said airoutlet, an air inlet sensor configured to measure air temperature orpressure or both; a blower situated in said air flow path and configuredto draw ambient air from said air inlet and force said ambient airthrough said air flow path and out said air outlet, a desiccant chambersituated in said air flow path and configured to receive a removable andreplaceable desiccant element; a heat sink situated in said air flowpath and configured to remove heat added to air in said air flow pathduring removal of moisture from said air by said desiccant element; anair outlet sensor configured to measure air temperature or pressure orboth; a liquid delivery subassembly comprising: a liquid pump,configured to interface with a flexible liquid supply tube and to forceliquid to be drawn into said flexible liquid supply tube from anexternal liquid source and out an outlet of said flexible liquid supplytube; wherein said air delivery subassembly and said liquid deliverysubassembly maintain isolation between said air flow path and saidliquid supply tube so that air in said air flow path and liquid in saidliquid supply tube do not come into contact at any time prior todelivery to said mammal.
 2. A device according to claim 1, wherein saidliquid pump comprises a peristaltic rotary pump.
 3. A device accordingto claim 1, further comprising a heat sink fan to blow ambient airacross a portion of said heat sink that is not in contact with said airflow path.
 4. A device according to claim 1, further comprising a secondair inlet connected to a solenoid valve for receiving pressurized airfrom a pressurized air source, said portable device further comprising asupplemental air flow path connecting said solenoid valve to saidblower.
 5. A device according to claim 1, wherein said liquid pumpfurther comprises pressure sensors to determine presence of liquid insaid liquid supply tube and a pressure of liquid in said liquid supplytube.
 6. A device according to claim 1, wherein a portion of saidflexible liquid supply tube is attached to a disposable cartridge, andwherein said liquid pump defines a recess configured to receive andengage said removable cartridge for alignment of said liquid supply tubewith said liquid pump.
 7. A device according to claim 1, furthercomprising a disposable manifold cartridge comprising: a manifold airinlet and a manifold air outlet connected by a manifold air flow path, aliquid supply flow path comprising a liquid supply tube attached to andsupported in said disposable manifold cartridge and configured to beconnected at one end to an external liquid source, said liquid supplytube comprising a section of tubing that enters and passes through saidmanifold air flow path and exits said manifold cartridge through saidmanifold air outlet.
 8. A device according to claim 7, wherein saidintegrated unit comprises an interface for receiving said disposablemanifold cartridge in which said manifold air inlet is received in saidair delivery subassembly air outlet, and wherein said liquid pumpdefines a recess configured to receive and engage a portion of saiddisposable manifold cartridge holding said liquid supply tube.
 9. Adevice according to claim 8, further comprising a locking mechanism forreversibly locking said disposable manifold cartridge into saidinterface and recess.
 10. A device according to claim 9, furthercomprising an air delivery tube configured to be connected at one end tosaid manifold air outlet and connected at a second end to a patientinterface assembly, said air supply tube comprising a lumen in which islocated a liquid delivery tube in fluid communication with said liquidsupply tube in said disposable manifold cartridge, and wherein air flowin said air delivery tube is isolated from and does not come in contactwith liquid in said liquid delivery tube.
 11. A device according toclaim 10, further comprising a patient interface assembly comprisingharness configured to rest against a patient's lip just beneath thenostrils, said harness defining one or more slots configured to slidabyreceive two tube connectors, said tube connectors each attached at adistal end to respective hollow elastomeric nasal pillows having abottom opening connected to a respective tube connector and a topopening for delivery of air to a patient's nostrils, said nasal pillowseach supporting within an interior space a nozzle assembly connected toa respective water delivery tube, said nozzle assembly arranged so thata distal tip of said nozzle assembly extends outside of said nasalpillow top opening a distance of 2-10 mm.
 12. A disposable manifoldcartridge configured to receive isolated air and water delivery pathsand combine them into an integrated delivery apparatus comprising: amanifold air inlet and a manifold air outlet connected by a manifold airflow path, a liquid supply flow path comprising a liquid supply tubeattached to and supported in said disposable manifold cartridge andconfigured to be connected at one end to an external liquid source, saidliquid supply tube comprising a section of tubing that enters and passesthrough said manifold air flow path and exits said manifold cartridgethrough said manifold air outlet.
 13. An apparatus for independentlydelivering isolated air and water streams to nostrils of a patientcomprising a harness configured to rest against a patient's lip justbeneath the nostrils, said harness defining one or more slots configuredto slidaby receive two air delivery tube connectors said air deliverytube connectors each attached at a distal end to respective hollowelastomeric nasal pillows having a bottom opening connected to arespective tube connector and a top opening for delivery of air to apatient's nostrils, said nasal pillows each supporting within aninterior space a nozzle assembly connected to a respective waterdelivery tube, said nozzle assembly arranged so that a distal tip ofsaid nozzle assembly extends outside of said nasal pillow top opening adistance of 2-10 mm.